GUEST COLUMNISTS

• AI Fills The Decision-Making Gaps In Process Analytical Technology

  When combined, artificial intelligence and PAT help move beyond reactive quality testing to proactive and anticipatory process management.

• Is mRNA Manufacturing Overbuilt?

  mRNA pipelines continue to advance, but has provider growth outpaced the pipeline? Let's take a closer look.

• CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And Culture

  Discover strategies for risk-based governance, AI-enabled quality management, stronger collaboration, and fostering a culture that supports long-term operational excellence.

• Using Digital Platforms To Find Your CDMO

  In recent years, digital platforms have emerged to help pharma/biotech companies discover, evaluate, and connect with CDMOs more efficiently. These resources have different functions and limitations.

• FDA Issues New Guidance On Therapeutic Equivalence

  The FDA has issued a new guidance document, Evaluation of Therapeutic Equivalence, clarifying the scientific and regulatory principles. What does this mean for drug developers and manufacturers?

• July 2026 — CDMO Opportunities And Threats Report

  Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

• ADC CDMO Selection For Small Biotech

  Manufacturing is a critical factor in ADC success. Discover how to align CDMO capabilities with molecule complexity, mitigate risks, and navigate capacity limits.

• Europe's ATMP Opportunity Still Requires Local Navigation

  European nations offer a welcoming environment for clinical-phase cell and gene therapies. Don't assume the same flexibility carries through to commercialization.